Intervention of Virtual Reality on Oculomotor Muscles and Balance
1 other identifier
interventional
34
1 country
1
Brief Summary
Prospective, controlled, randomized, non-masked longitudinal research project for the realization of a doctoral thesis, based on an intervention with virtual reality in order to assess whether the influence on balance and the oculomotor muscles is positive. The introduction of new technologies in the field of medicine in all fields, and in particular the rehabilitation is fully in place and under development. There are numerous examples like these technologies, including virtual reality (VR), have helped different health fields such as surgery or physiotherapy. The main aim of the study is to analyze these factors and analyze the way in which virtual reality (VR) can modulate the convergence of the gaze and can influence the center of pressure (COP). As secondary objectives es proposes to analyze the interrelationship between the VR and the COP to analyze the clinical possibilities of application in the field of rehabilitation, whether due to a downward (oculomotor) or upward alteration (COP alteration), as well as if physical activity or gender can also influence.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2022
CompletedFirst Submitted
Initial submission to the registry
November 30, 2022
CompletedFirst Posted
Study publicly available on registry
December 14, 2022
CompletedDecember 14, 2022
December 1, 2022
6 months
November 30, 2022
December 11, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline Centre Of Pressure at 7 days after 12th session
The pressure center (COP) is the point where the resulting reaction forces with the ground is applied to the support base. The oscillation of the individual with respect to the ground is projected in an anteroposterior line (AP) and a mediolateral line (ML). With these two parameters, the total route covered by the COP can be defined. An alteration of balance can be objectified by measuring an increase in the same area; reflecting a loss of control of the AP and ML axes and a slowdown in the perception of this loss.
Day 1 and 7 days after the 12th session.
Secondary Outcomes (1)
Change from Baseline PPC at 7 days after 12th session
Day 1 and 7 days after the 12th session.
Study Arms (2)
Virtual Reality Game Group
EXPERIMENTALA total of 24 interventions will be carried out for each participant, separated by 2 each week for 3 months. Each intervention will consist of a VR session lasting 30 minutes. Each participant must play for 30 minutes in the game "Beat know". The game consists of cutting mobile targets, using lightsabers while avoiding obstacles that approach the user. This game is a reference for immersive play since, while distracting, it recreates a physical activity similar to what would be done in reality. It has been shown that the same energy expenditure, on the part of the user, practicing tennis in real life, is what he does playing "Beat Saber" playing the same period of time.
Control Group
NO INTERVENTIONNo intervention during 12 weeks.
Interventions
The game consists of cutting mobile targets, using lightsabers while avoiding obstacles that approach the user. This game is a reference for immersive play since, while distracting, it recreates a physical activity similar to what would be done in reality. It has been shown that the same energy expenditure, on the part of the user, practicing tennis in real life, is what he does playing "Beat Saber" playing the same period of time.
Eligibility Criteria
You may qualify if:
- Age between 18 and 25 years old.
- No visual alteration.
- No history of vertigo.
- No pathology that compromises balance.
- Physically active (where the first two questions are affirmative and are 3 days and 3 hours, respectively.
You may not qualify if:
- Taking medication that affects the nervous and/or motor system.
- Smoking, alcoholism, taking illicit drugs or neurologically active medications.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Escoles Universitaries Gimbernat
Sant Cugat del Vallès, Barcelona, 08174, Spain
Related Publications (23)
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PMID: 32577736BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Sergio Gomez Doctor, PT, MsC
E.U. Gimbernat
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2022
First Posted
December 14, 2022
Study Start
January 1, 2022
Primary Completion
June 30, 2022
Study Completion
September 30, 2022
Last Updated
December 14, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share